Delivery preparation and facilitation device and preparatory gymnastics

ABSTRACT

A device for preparing a pregnant woman to delivery and facilitating the delivery itself, which comprises an entirely expandable stretch body, which is positioned in the expulsion area of the urogenital canal in such a way that it is partly inside the vagina and partly outside. There is also disclosed a preparatory gymnastics method involving the inventive device.

The present invention relates to a device for helping a pregnant womento prepare for giving birth and to make giving birth easier which has anexpandable elongated body which is positionable in the region of thevaginal orifice such that it is located partly inside the vagina andpartly outside of the vagina. The invention further relates to anexercise method involving the use of such a device for preparing to givebirth.

In Germany, there are approximately 850,000 births per year. Accordingto the most recent available perinatal statistics of 1995, the rate ofepisiotomy, among both first time and subsequent births, was a total of58.9% (less the rate of cesarean section of 17.4%). This means thatapproximately 500,650 epiosotomies are carried out yearly in Germany(Commission for Perinatalogy and Neonatalogy, BPE Annual Report 1995).In about 20% of all births a tear in the perineum occurs as a result ofwhich the risk of death due to complications is further increased. Inspite of numerous traditional and modem methods for preparing and forfacilitating giving birth (e.g. Leboyer, Read, Odent), the mentionedstatistics remain unchanged in relation to one another after decades.Even the new age pregnancy exercises to prepare for giving birth and thepregnancy consultation of midwives have only improved these figuresunsubstantially.

The episiotomy, first described by Ould in 1742, still conjures up ahorrible image even after 250 years. Although, it was proposed andcarried out as a relief for women and to accelerate delivery, it isstill feared by many women to this day due to its painfulness, and it ishated for its negative consequences. Avoidance of the episiotomy hastherefore been a long felt need in the field along with the goal to makethe delivery easier for mothers with less fear involved.

An additional problem of modem birthing assistance is the increasingdisproportion between the fetal/infant head and the female pelvis. Thecranial circumference of newborns is steadily increasing such that themeasurement program established by Hausmann for the standard size of thebiparietal diameter using ultrasound must be continuously upwardlycorrected. The cause for this might be seen, on the one hand, to be theresult of increasing exposure of pregnant women to light, noise, andother stimulation (for example neon lights, electro smog, car noise, etc. . . ), and on the other hand, due to the natural, modem androgenoustype of woman (tall, narrow female pelvis and narrow hips) whichnaturally makes giving birth more difficult.

It is known for treating sedimentation of the blood and incontinenceproblems in women to insert an inflatable balloon deep into the vaginain order to provide, in the inflated state, a mechanical blockage of thebladder while raising the uterus. For example, European Patentpublication EP 0,663,197 A1 describes a support body which keeps itsshape and is made of elastic rubber material with areas of differentwall thickness which expands conically from a base region in thedirection of a top surface at the opposite end of the support body in aconical manner, a piece of hose being sealingly connected to the baseregion. The top surface is reinforced in a ring-shape and has a softconcavely formed inner region. The support body is inserted into thevagina with the base downward and is left in place for hours to supportthe vaginal wall.

U.S. Pat. No. 3,626.949 describes a cervical dilator which has nothowever achieved any significant success in practice. It discloses a PVCenvelope or case having a hose connection for filling up the case with afluid under pressure. The case can be inserted into the cervical canalwhile folded up and is then periodically expanded under pressure suchthat the case expands radially against the cervical wall to therebysimulate contractions. Between opposed ends of the case there is a waistportion which is not expandable in a radial direction, which waistportion is positioned inside the edge of the cervix in order to preventthat the expanded waist portion moves in an axial direction underpressure.

A further cervical dilator is described in U.S. Pat. No. 3,480,017. Thisdilator uses an inflatable case which is inflatable to a substantiallydisk-shaped body, which is positioned in use inside the uterus andinflatable using an inflation tube whose opening is inside the case. Thecase comprises a circumferential constriction such that a groove isformed in the cylindrical exterior wall of the case when inflated into adisk. The cervix supported by the groove can be expanded in this way inorder to induce birth. The application of the known device is onlypossible by a doctor who has acquired the skills to manipulate the shellagainst the cervix using the inflating tube as a handle, withoutdamaging the amniotic sack or the fetus' head. As a result of its flatdisk shape, the known cervical dilator is particularly suited only forthis application.

In French Patent publication FR-592,104, there is described a dilator tobe inserted in the perineum which is made of an elongated elasticmaterial balloon which can be laterally expanded by inflation whilehaving its lengthwise expansion limited. By methodical use andprogressive expansion, tissue having undergone such exercise will yieldwhile giving birth without tearing.

This prior art balloon can also be actuated intermittently using athree-way valve. During use, it is important to pay attention that theballoon is only inserted into the vagina to the extend that the middlesection of the balloon rests in the area of the perineum. Duringinflation, the balloon should form inside the perineum a ring-shapedconstriction by means of which the balloon is secured in the axialdirection.

In the embodiment of this prior art in which the balloon has a centralinflation tube, there is the danger that the inner end of the tube ispushed during insertion too close to the cervix where serious injury ispossible (causing bleeding or breakage of the amniotic sack).

In the case of the embodiment in which the balloon is provided withnon-stretchable inner strips for preventing a lengthwise extension ofthe balloon, there is the danger that the balloon will be suddenlycatapulted inwardly towards the cervix during inflation once apredetermined level of inflation is reached, which can lead to theabove-mentioned serious injuries.

The known device should therefore only be used under the supervision ofa physician, in particular because it is practically impossible for apregnant woman, due to the corresponding size of her abdomen, to locatethe correct axial position of the balloon.

Accordingly, it is the object of the present invention to construct theabove-mentioned device such that its application for a pregnant women ispleasant and safe, and can be carried out easily by herself; and,finally such that its use should substantially contribute to thesignificant reduction of perineum tearing or episiotomies occuringduring birth. Associated therewith, an undesired drop in the pelvicfloor, and later occurrences of bladder incontinence and sexualdisturbance as a result of physiological and psychosomatic complicationsoccurring postpartum can be prevented.

This object is provided by a device having the characteristics of claim6 as well as a method having the characteristics of claim 1.

The device according to the invention comprises an expandable elongatedshaped body which is positionable in the region of the vaginal orificesuch that it is located partway inside the vagina and partway outsidethe vagina. By the expansion of the elongated body, the vagina can besubstantially expanded and the birth canal as well as the vaginalorifice can be expanded in advance to facilitate giving birth. With thistraining and stretching effect, eposiotomies as well as an undesirabledrop in the pelvic floor can be avoided to a large extent along withcomplications associated therewith. The expandable body maintains itsdistance from the cervix which it should never contact in order avoidirritations.

By shaping the expandable elongated body such that the shape facilitatesits positioning in the area of the vaginal orifice, the device isself-centering in the region of the vaginal orifice and self-anchoring.This can be achieved for example by shaping the body as a FIG. 8 in itslengthwise axis. It is essential that the expandable body is expandablein its entirety (i.e. the whole shape expands), since specifically theexpansion in the area of the vaginal orifice is to be exercised.

In accordance with a preferred embodiment, it is provided that the bodyis expandable by means of a variable fluid filling system. The fluid canbe for example a gel or an aqueous liquid which may be temperaturecontrolled if need be, or the fluid may be a gas such as air. Inparticular cases, air pressure provided by blowing with the mouth may beused. Also preferably, the body may be formed as a balloon having afilling tube connected to an end which during use is orientedexternally. Latex or a silicone product are examples of skin compatiblematerials which may be used.

According to a preferred embodiment, the balloon is assembled from twoparts or half-shells which are connected together along acircurmferential seam. The circumferential seam is preferably positionedin the area of the waist portion. The half of the device positionedoutside of the vagina has a greater wall strength than the halfpositioned inside. In this way, it is provided that the balloon isself-stabilized under high pressure and leads to a minimal rise inpressure for vaginal dilation.

In a further preferred embodiment, the device comprises an air pump witha manometer or pressure gauge connected to the filling hose of theballoon. The pump which may comprise a hand-pump can be used to pump upthe expandable body in steps or stages up to a maximum pressure whichmay be about 160 mm Hg, measured using the pressure gauge.

The pressure gauge preferably comprises an air-release screw which isused to release the pressure at the end of the therapy or for reliefduring use.

Finally, it is important to make sure that the maximum expansion of theballoon transversely to the lengthwise axis measures 9 to 10 cm,preferably 9.4 to 9.6 cm. This corresponds approximately to the averagediameter of a newborn head with a cranial circumference of approximately35 cm at birth.

A further embodiment provides that a safety valve be arranged on thepressure gauge in order to limit the maximum pressure. The pressure maybe limited, for example, to 200 mm Hg. The safety valve opens when thepressure limit is exceeded.

According to another preferred embodiment, the balloon assembled fromtwo-half shells is constructed such that the half shelves form twogas-tight chambers separated from one another. In this way, they can beeach indepentently filled or deflated such that the balloon can beadjusted to the individual needs of the patient. The hose for inflatingand deflating the half-shell positioned inside the vagina is provided topass through the other half-shell. Both hoses exit at the end of theballoon directed outwardly. The device is particulary advantageous forpatients who have already given birth and who have during the previousbirth endured tearing of the perineum leading to painful scarring. Forthis purpose, the device can be pumped up alternatingly in pressuresteps of 10 mm Hg in order to exert pressure on alternating sides of thevaginal orifice.

In a further preferred embodiment, the half shell positioned in thevagina is fillable by means of a separate inflation hose. The separatefilling hose can either pass outside of the device or through the insideof the half-shell positioned outside of the vagina such that both tubesextend outwardly from the birth canal. Furthermore, according to avariant embodiment, the two hoses extend concentrically one inside theother.

Finally, it preferred that the device comprises a three-way valve forselecting the filling mode of the two half-shells. The two separatedfillable half-shells can be filled together or individually inflated.The filling pressure is monitored for each corresponding filling modeusing the pressure gauge. Also, the order for deflation can be selectedusing the three-way valve. When using concentrically extending hoses, acorresponding constructively built three-way valve can be provided.

In addition to the above-mentioned device, the invention further relatesto a method for preparing to give birth using exercises in which thedevice according to the invention is used such that the expandable bodyis positioned partly outside and partly inside the vaginal orifice, andthereafter is expanded to a desired size and finally maintained in anexpanded state for a predetermined time in its position. Preferably, theexpansion of the device is increased with each repeated use in order toachieve an increasing preparatory expansion of the birth canal. Themethod carried out as a stretching or expansion exercise should becarried out several times per day as of the thirty-sixth week ofpregnancy. Additionally, it is preferable that the expanded body beremoved carefully in a direction of the vaginal orifice after apredetermined time period. The time period that the device should remainin the birth canal is between 10 to 20 minutes, preferably 15 minutes,in accordance with the subjective feeling of the patient: too muchstretching tension indicates too high a pressure in the balloon. Reliefis achieved by the step-wise actuation of the air pressure releasescrew.

The numerous advantages of the mentioned method are: an easier deliveryresulting from prior stretching or expansion of the birth canal and theouter vaginal orifice; a faster delivery, in particular in the case offirst time mothers; better oxygen supply to the child as a result ofminimal pressure on the fetal cranium as it emerges; a reduction oflabor-inducing medication, in particular in the case of first timemothers; a reduction in the pain of childbirth and minimal crampingcaused by stretchable musculature; a clear reduction in the use of painkillers and local anesthesia; less risk of allergic shock due to localanesthesia; a reduction in the use of peridural and epidural anesthesia(spinal cord anesthesic); a significant reduction in the need to resortan episiotomy which is always painful for the mother (and thereforefeared by her) and the inevitable stitches following the episiotomy; aswell as a quicker recovery of the vaginal musculature by sparing themusculus bulbo cavernosus, musculus bulbo spongiosus and the musculussphincter ani since the incidence of macro and micro muscle tearing isreduced.

Further advantages resulting from a problem-free delivery are bettercare of the child by the mother, who can be more active and agile in theabsence of an episiotomy, such that she can care for the child herselfwithout feeling sick and injured. As a result of the reduction of painachieved according to the invention, the production of prolactine isincreased whereby lactation (breast feeding) is improved. It isfurthermore important that the physiology, function and appearance ofthe vagina and vulva are maintained to a large extent, and thereby themother's sex life after giving birth is not affected. A shorter recoverytime in hospital and the possibility of home birth may also contributeto relief of medical insurance plans.

The invention will be better understood by way of the following detaildescription of a preferred embodiment with reference to the appendeddrawings in which:

FIG. 1 illustrates a preferred embodiment of the device according to theinvention in use in the deflated state;

FIG. 2 illustrates the embodiment as shown in FIG. 1 in which the deviceis in the expanded state;

FIG. 3 illustrates a cross-section of the embodiment of the deviceaccording to FIGS. 1 and 2; and

FIG. 4 shows a cross-section of a further embodiment of a deviceaccording to the present invention.

FIGS. 1 through 3 illustrate a balloon 1 for pneumatic dilation of thebirth canal which is inserted into the vagina 2 towards the cervix 7 ofuterus 10. The oval and FIG. 8 shaped expandable balloon 1 having amiddle neck or waist portion 15 comprises, in its half 14 positionedexterior of the vagina 2, a greater wall strength than the half 13positioned inside. The waist portion 15 of the balloon 1 itself isreinforced. The balloon 1 when deflated and folded up is inserted intothe vagina 2 with lubricating gel such that approximately three to fourcentimeters of the balloon 1 can be seen in front of vulva 3. This isimportant since the outermost portion of the vagina 2 in particular, andabove all, the vaginal orifice 4 should be expanded. This is the mostsensitive part of the female birth canal and due to the danger of a tearof the perineum, it is at the same the most endagered anatomical part.The balloon 1 is now carefully pumped up using hand-pump 5 in steps of20 mm Hg up to a maximum pressure of 160 mm Hg, which is monitored usingmanometer or pressure gauge 6. The stretching feeling subjectivelyexperienced by the pregnant woman sets the limit for inflation. Afterapproximately 15 to 20 minutes, the device 1 is carefully and gentlypulled out in the direction of the vagina so that the patientexperiences a “feeling of giving birth” and this sensation can bedeepened in subsequent exercises which leads to a considerabletranquilizing effect. This exercise is repeated several times per daysuch that the patient expands the vaginal orifice continuously andcompletely painlessly. It is important that the desired diameter of theballoon is measured by corresponding pumping (i.e. by counting the pumpstrokes) outside of the vagina. The pressure on the pressure gaugeshould never exceed 200 mm Hg. The scale of the pressure gauge iscorrespondingly marked.

The maximum diameter of the waist portion should be 9.5 cm since thebiparietal diameter of fetal cranium at birth is on average of thissize, which corresponds to a cranial circumference of 35 cm. If anultrasound examination carried out by the medical doctor determines thatthe child is particularly larger, the diameter of the expansion can besimply increased accordingly. However, the patient should still controlthe size of the balloon to suit her subjective feeling.

As a basis of measurement for the required birth dilation pressures, thefollowing test results can be used:

According to scientific studies by R CALDEIRO-BARCIA the intraamnialpressure can rise under normal contraction activity up to 100 mm Hg. Thesystolic blood pressure of the mother (normally 120 mm Hg) can risebriefly during contractions during the period of expulsion up to between180 to over 200 mm Hg. The pressure of the uterus musculature reaches,towards the end of the expansion during delivery, a pressure of up to200 mm Hg against the surrounding vaginal tissue. According to C.LINDGREN, the maximum pressure on the fetal cranium in the area of theperineum 8 can reach a peak value up to 300 mm Hg during contractionsshortly before birth. In order to keep the artificial dilation describedherein within the physiological range, a limit of 200 mm Hg isrecommended. Basically, the dilation should not be carried out beforethe 36th week of pregnancy.

The demonstration and explanation of the method for dilating the birthcanal should basically be carried out with the patient by the physicianin charge or by the midwife. It is recommended to carry out the firstdilation under continuous CTG control (cardio topography=continuousrecordal of fetal heart sounds and contractions) by the physician incharge or the midwife.

Cleaning of the device after use can be done with soap and water and airdried. Disinfecting using commercially available disinfectants isrecommended.

FIG. 3 shows further the hose connection 16 as well as the expandableballoon 1 in its expanded state 17. The two parts or half-shells 13, 14are glued or joined together overlapping about a circumferential seamwhich coincides with the waist portion 15. The overlapping region isshown in dashed lines.

FIG. 4 shows a cross-section according to a further embodiment accordingto the present invention. The parts or half-shells 21, 22 and theballoon 20 are shown. In the area of the waist portion 23, a membrane 24is arranged inside the balloon which membrane comprises an opening 25which is connected to a first hose 26. The outer half-shell 22 isconnected by means of a wall orifice 27 to a further connecting hose 28.The two connecting hoses 26, 28 are connected to a three-way valve 29which in turn is connected by a hose 30 to a pressure gauge 21 andhand-pump 22. An air-release screw 33 is also provided between pressuregauge 31 and hand-pump 32 as well as an elastic seam 34 where the firstconnecting hose 26 passes through the wall of the outer half shell 22.

In the embodiment according to FIG. 4, three configurations can beselected using three-way valve 29. In the first configuration, aconnection is established between hose 30 and both connecting hoses 26,28. In this way, both chambers, i.e. both parts or half shells 21, 22are simultaneously inflated or deflated. In the next configuration, aconnection between hose 30 and connector hose 26 is established for theinner half-shell 21, whereby the connection to the second connector hose28 is interrupted. In a third configuration, a connection is establishedbetween hose 30 and connector hose 28 to the outer half-shell 22 wherebythe connection to the other connector hose 26 is interrupted. In thisway, the outer half shell 22 can be inflated using the hand-pump 32 ordeflated by means of the air-release screw 33. The connector hose 26 tothe inner half shell 21 extends through the outer half-shell 22 directlyto the membrane 24 where hose 26 connects to the opening 25 in membrane24. As a result of such a twin-chamber construction, the volume ofballoon 20 can be individually adjusted to the needs of the user. Thepressure of each individually controlled balloon chambers can beseparately monitored using pressure gauge 31.

What is claimed is:
 1. An exercise method for preparing to give birthusing a device for preparing to give birth, the device comprising: anexpandable elongated body which is positionable in the area of thevaginal orifice such that it is located partly inside the vagina in avaginal interior and partly outside the vagina during use, the body isadapted to be expandable in its entirety, wherein the body furthercomprises a first expandable portion, a second expandable portion and awaist portion defined therebetween, said first expandable portion havingan end that is adapted for insertion into the vaginal interior and thatis uninterrupted by any portion of said device extending therethrough,said defined waist portion being expandable along with the remainder ofthe body, the waist portion being adapted to expand the vaginal orificein preparation for giving birth, the waist portion being adopted to beself-centered in the area of the vaginal orifice during use, the waistportion being constricted with respect to the remainder of the bodybefore insertion of the device through the vaginal orifice, during useof the device and after withdrawal of the device through the vaginalorifice, wherein said first expandable portion and said waist portionare configured to expand the vaginal interior and vaginal orificerespectively to mimic the extent of expansion that would occur whilegiving birth, and wherein said first expandable portion is positionedwithin said vaginal interior such that said first expandable portiondoes not contact the cervix during use, the exercise method comprisingthe steps of: positioning the expandable body partly within the vaginalinterior and partly outside and the vaginal orifice with the waistportion being self-centered in the area of the vaginal orifice, andthereafter expanding the expandable body to a desired dimension suchthat the waist portion is expanded to expand the vaginal orifice andsaid expandable body is expanded to expand said vaginal interior andwithout contacting the cervix, and maintaining the body in the expandedstate for a predetermined time in its position.
 2. Method according toclaim 1, wherein the expansion of the expandable body is increased withrepeated use in order to achieve an increasing preparatory stretching ofthe vaginal interior.
 3. Method according to claim 2, wherein theexpandable body is pulled from the vagina after a period of time. 4.Method according to claim 3, wherein the time period is between 10 to 20minutes.
 5. Method according to claim 3, wherein the expansion of thewaist region is selected to be up to a diameter of 10 cm.
 6. Deviceaccording to claim 5, characterized in that the outer and innerhalf-shells form two air tight chambers separated from one another. 7.Device according to claim 6, characterized in that the half-shellinsertable in the vagina is inflatable by means of a separate inflationhose.
 8. Device according to claim 6, characterized in that the devicecomprises a three-way valve for selecting the inflation mode of theouter and inner half-shells.